GBA Pharma boss Elisabeth Lackner, the consignory for test pills

Elisabeth Lackner now knows her way around the conference facilities at the legendary Westin St. Francis luxury hotel, centrally located on San Francisco's Union Square, with a glass elevator overlooking the city. For years she has been attending the most important pharmaceutical conference there, which the US investment conference JP Morgan always organizes at the beginning of January. In the corridors, she welcomes industry colleagues from all over the world and follows with great interest the fact that this year again several CEOs took the time to talk about the most important pharmaceutical trends in the US election year. "We have become so important that we have to be present at this important industry event," explains the petite pharmaceutical entrepreneur confidently.

Lackner, who studied pharmaceutics, has built up the pharmaceutical service provider ABF Pharmaceutical Services from Vienna over the last ten years. The company has grown up in an area that pharmaceutical giants are increasingly outsourcing: project management and the handling of clinical studies when the preparations are tested on patients for the first time. "More than 250 clinical development studies are running across our desk, which we implement for the world's largest pharmaceutical companies, but also for up-and-coming biotech companies," says Lackner. For example, ABF, which she built up and is based in the 23rd district of Vienna, was the first pharmaceutical service provider in Europe to implement clinical studies in personalised medicine from Vienna in 2014. Specifically, the project involved an immunotherapy against prostate cancer on behalf of a US biotech company. Other important study topics are currently oncology and cell-based therapies.

Vienna-based pharmaceutical service provider

The largest studies that Lackner has supervised had up to 5,000 patients in more than 30 countries. ABF then takes over the import of the test preparations, filling and export to the participating clinics on behalf of the pharmaceutical companies. "We have to come up with a concept that guarantees patient safety and takes costs into account," says Lackner. If, for example, large quantities of tablets are delivered in canisters, Lackner and her team have to find a packaging that guarantees the same efficacy of the test preparations. "We then test whether the tablets work just as well in an overcapsule, whether they are just as stable or whether they dissolve just as well," explains the entrepreneur. If the test results are positive, she organizes the shipment of the test preparations and the identically packaged placebo to the participating clinics around the world. Studies on rare diseases are a particular challenge. "Here it can happen that a patient suddenly turns up in India and we have to find a solution overnight how to get the test preparation there safely by the next day," she says.

In Austria, ABF is the only full-service provider with this special focus. This has led to a prospective buyer to come knocking. In 2016, for example, a medium-sized German group called GBA Group, which is one of the leading laboratory service providers in Europe, wanted to strengthen its pharmaceutical business with ABF in Vienna. This time Lackner decided to sell - and with it a new career option: as managing director of GBA Pharma, she is now responsible for around €50m in sales - and thus half of the total proceeds (see box). She also has a stake in the group, but is silent about the exact amount. "Yes, I have a stake," she says. Her strong position within GBA is also a result of the dynamic growth of the division for which she is responsible: "We are growing at least ten percent per year, which is well above the industry average," she says. Most of the orders come from Europe and North America. Increasingly, Asian customers are also turning to Lackner, which intends to build up its own local service providers through acquisitions over the next three years. In doing so, she is also continuing the aggressive growth strategy in the pharmaceuticals sector, which characterises the entire GBA Group, which is also financed by private equity.

Brexit chaos

Some of the money was recently channelled to Vienna, where the location was greatly expanded. This was also done against the background of Brexit and the growth opportunities it offered. After all, with the UK's decision to leave the EU at the end of January, many pharmaceutical companies are facing a situation of legal uncertainty virtually overnight. For example, EU laws stipulate that medicines to be sold in the EU must also be produced and stored on European soil. At present, however, a not inconsiderable proportion of the drugs are manufactured in Great Britain. This leads to great uncertainty among many clients: "We have already received numerous enquiries from pharmaceutical companies that are considering moving the handling of their clinical studies to Vienna in the future," says Lackner, who is a sought-after speaker at many International symposia on the complex EU regulations. Last time she was in New York, soon she'll be going to San Francisco. "I am also a mother and a wife. Of course, family comes first for me," says the manager and laughingly says goodbye to the next appointment.